「MRNA-1273」の版間の差分
削除された内容 追加された内容
{{pp-vandalism|small=yes}} |
|||
36行目:
7月9日、モデルナは、自社のワクチンが承認された場合に備えて、ラボラトリ・ファーマシューティカル・ロビ社とのインフィル製造契約を発表した<ref>{{cite web|url=https://www.marketwatch.com/story/moderna-signs-on-for-another-covid-19-vaccine-manufacturing-deal-2020-07-09|title=Moderna signs on for another COVID-19 vaccine manufacturing deal|publisher=MarketWatch| last = Lee | first = Jaimy | name-list-style = vanc |access-date=9 July 2020|archive-date=16 November 2020|archive-url=https://web.archive.org/web/20201116154219/https://www.marketwatch.com/story/moderna-signs-on-for-another-covid-19-vaccine-manufacturing-deal-2020-07-09|url-status=live}}</ref>。
2020年7月14日、モデルナの科学者は、mRNA-1273の第I相用量漸増臨床試験の予備結果を発表し、注射後15日目という早い時期にS1/S2に対する中和抗体の用量依存的誘導を示した。[[発熱]]、倦怠感、頭痛、[[筋肉痛]]、注射部位の痛みなどの軽度から中等度の[[副
2020年7月、モデルナは、[[治験#phase1trial|第I相臨床試験]]において、[[Operation Warp Speed]]の候補薬が、健康な成人において[[中和抗体]]の産生につながったことを速報で発表した<ref name="jackson">{{cite journal | vauthors = Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH | display-authors = 6 | title = An mRNA Vaccine against SARS-CoV-2 - Preliminary Report | journal = The New England Journal of Medicine | volume = 383 | issue = 20 | pages = 1920–1931 | date = November 2020 | pmid = 32663912 | pmc = 7377258 | doi = 10.1056/NEJMoa2022483 | doi-access = free }}</ref><ref>{{cite web|url=https://www.cnbc.com/2020/07/14/stock-market-futures-open-to-close-news.html|title=Dow futures jump more than 200 points after Moderna says its vaccine produces antibodies to coronavirus| first = Yun | last = Li | name-list-style = vanc |publisher=[[:en:CNBC|CNBC]]|date=14 July 2020|access-date=15 July 2020|archive-date=16 November 2020|archive-url=https://web.archive.org/web/20201116154335/https://www.cnbc.com/2020/07/14/stock-market-futures-open-to-close-news.html|url-status=live}}</ref>。「モデルナがより大きな試験で進める100マイクログラムの用量では、15人の患者全員が疲労、悪寒、頭痛、筋肉痛、注射部位の痛みなどの[[副
=== 第III相試験 ===
45行目:
2020年9月、モデルナは臨床試験の詳細な試験計画を発表した<ref>{{cite web|title=Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial|url=https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-study-protocol-november/585386/|access-date=2020-09-18|website=BioPharma Dive|archive-date=16 November 2020|archive-url=https://web.archive.org/web/20201116154224/https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-study-protocol-november/585386/|url-status=live}}</ref>。9月30日、CEOのStéphane Bancelは、試験が成功すれば、早ければ2021年3月下旬か4月上旬にワクチンが一般に提供される可能性があると述べた<ref>{{cite web |last=Mascarenhas |first=Lauren| name-list-style = vanc |date=1 October 2020|title=Moderna chief says Covid-19 vaccine could be widely available by late March |url=https://www.cnn.com/2020/10/01/health/moderna-coronavirus-vaccine-bancel-bn/index.html|url-status=live |archive-url=https://web.archive.org/web/20201116154301/https://www.cnn.com/2020/10/01/health/moderna-coronavirus-vaccine-bancel-bn/index.html|archive-date=16 November 2020 |access-date=2020-10-02 |website=CNN}}</ref>。2020年10月の時点で、モデルナは第III相試験に必要な3万人の参加者の登録を完了していた<ref>{{cite web |first=Elizabeth | last = Cohen | name-list-style = vanc |title=First large-scale US Covid-19 vaccine trial reaches target of 30,000 participants|url=https://www.cnn.com/2020/10/22/health/moderna-covid-19-vaccine-trial-30000-participants/index.html|access-date=2020-10-23|website=CNN|archive-date=16 November 2020|archive-url=https://web.archive.org/web/20201116154329/https://www.cnn.com/2020/10/22/health/moderna-covid-19-vaccine-trial-30000-participants/index.html|url-status=live}}</ref>。アメリカ国立アレルギー・感染症研究所は、2020年11月15日に、全体的な試験結果が良好であったと発表した<ref>{{cite web|title=Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine|url=https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine|website=National Institutes of Health (NIH)|date=15 November 2020|accessdate=2021-02-20}}</ref>。
2020年12月30日、モデルナは[[治験#phase3trial|第III相臨床試験]]の結果を発表し、COVID-19の感染予防に94%の有効性を示した<ref name="Baden">{{cite journal |last1=Baden |first1=Lindsey R. |title=Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine |journal=New England Journal of Medicine |date=30 December 2020 |pages=NEJMoa2035389 |doi=10.1056/NEJMoa2035389|doi-access=free }}</ref><ref name="cnbc11-16">{{cite news | first1 = Berkeley | last1 = Lovelace Jr | first2 = Noah | last2 = Higgins-Dunn | name-list-style = vanc |title= Moderna says preliminary trial data shows its coronavirus vaccine is more than 94% effective, shares soar|url=https://www.cnbc.com/2020/11/16/moderna-says-its-coronavirus-vaccine-is-more-than-94percent-effective.html |access-date=17 November 2020 |work=CNBC |date=16 November 2020}}</ref><ref name="NYT-20201120">{{cite news |last=Zimmer |first=Carl | name-list-style = vanc |author-link=Carl Zimmer |title=2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean? You might assume that 95 out of every 100 people vaccinated will be protected from Covid-19. But that's not how the math works. |url=https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html |date=20 November 2020 |work=The New York Times |access-date=21 November 2020 }}</ref>。[[副
2020年11月、''[[Nature (journal)|Nature]]''誌は、「LNP製剤の違いやmRNA二次構造の違いが、モデルナとバイオンテックの熱安定性の違いを説明する可能性はあるが、多くの専門家は、両方のワクチン製品が最終的にはさまざまな温度で同様の保存要件と保存期間を持つことが証明されると考えている」と報告している<ref name="nature1">{{cite journal | vauthors = Dolgin E | title = COVID-19 vaccines poised for launch, but impact on pandemic unclear | journal = Nature Biotechnology | date = November 2020 | pmid = 33239758 | doi = 10.1038/d41587-020-00022-y | s2cid = 227176634 }}</ref>。
| |||